A New Micro Swim-up Procedure for Sperm Preparation in IC... | NCT02672124

Studies
A New Micro Swim-up Procedure for Sperm Preparation in ICSI Treatment

NCT02672124

Sponsor

Cervesi Hospital, Cattolica, Italy

Status

Unknown status

Last Update Posted

Feb 9, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Microswimup Procedure Efficacy

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Dec 2021Estimated

Completion Date

Jan 2022Estimated

First Submitted Date

Jan 19, 2016

First Submission Date that Met QC Criteria

Jan 29, 2016

First Posted Date

Feb 3, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2021

Last Update Posted Date

Feb 9, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Palini Simone, Embryologist, Cervesi Hospital, Cattolica, ItalyPrincipal Investigator

Lead Sponsor

Cervesi Hospital, Cattolica, ItalyOTHER

Collaborators

Not provided

Description Module

Brief Summary

The aim of this study is to evaluate the microbiological safety and the efficacy of a new not expensive, easy and fast technique (Direct Microswimup) for sperm preparation in In Vitro Fertilization (IVF) treatments without the use of centrifuge, able to simplify the procedure and to avoid mismatches by ensuring the same results of the standard techniques in terms of fertilization rate, blastulation rate, pregnancy/abortion rate, cryostorage rate, and a better euploid status of the embryos.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
microbiological test	A standard bacteriological culture [based on inoculation of blood and "chocolate" agar plates and Brain-Heart Infusion broth, followed by incubation at 37°C for up to 72 hours] was performed in order to investigate the presence and amount of colonizing bacteria delivered with the semen at ejaculation and after treatment	3 months

Secondary Outcomes

Measure	Description	Time Frame
semen treatment efficacy	number of obtain blastocysts (%) and number of pregnancy (%)	6 months

Other Outcomes

Measure	Description	Time Frame
euploid status	molecular analysis of blastocyst's biopsy	6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

at least 8 oocytes retrieved at pickup
oocyte insemination with ICSI technique
only elective single embryo transfer (eSET) at blastocyst stage
sperm concentration ≥ 1 X 106 /ml
absence of antibiotic treatment in the previous four weeks for male patients

Exclusion Criteria:

recurrent miscarriages
more than three in vitro fertilization treatment
azoospermia

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

This study included couples submitted to in vitro fertilization treatment at the Unit of Physiopathology of Reproduction (Cervesi Hospital, Cattolica, RN, Italy).

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cervesi Hospital IVF Unit	Recruiting	Cattolica	Rimini	47841	Italy